Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Adenoma

Adenoma, Islet Cell

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Antineoplastic Agents, Immunological

The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with various types of cancer with EGFR overexpression. The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.

Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.

Fudan University

Professor

Symptoms and General Pathology

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

UCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes

Hereditary Cancer Panel

Paige Steiding

Randy Hecht, MD

Paul Fanta, MD

Emily Bergsland, MD

This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms (PanNEN). This protocol is an extension of existing Genetic Testing Station efforts at University of California, San Francisco (UCSF)

PRIMARY OBJECTIVE:

I. To assess the frequency of germline mutations in patients with PanNEN.

SECONDARY OBJECTIVES:

I. To assess the rates of different types of germline mutations in patients PanNEN.

II. To assess the rates of different types of variants of uncertain significance in patients with PanNEN.

III. To estimate the rate of completion of genetic testing in patients who are offered prospective germline testing.

EXPLORATORY OBJECTIVES:

I. To examine attitudes of patients who have completed germline testing.

II. To explore reasons for declining germline testing.

III. In patients with repeat germline testing, compare the frequency of germline alteration between tests.

IV. Assess the relationship between germline pathogenic variants and somatic mutations in PanNEN.

OUTLINE:

Potential eligible participants will be identified via chart review and invited to consent to the study. Study participants who agree to prospective testing and have not had previous large panel germline testing will watch an informational video about germline testing and be offered testing with University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel. Study participants who decline germline testing will be asked to answer a one-question Declination Survey. Results will be shared with participants and their providers per the standard of practice at each participating study site. All participants who decided to receive germline testing will be asked to complete a decision survey.

Saliva samples will be obtained from participants

Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms

The overall percentage of participants with pathogenic, or likely pathogenic germline mutations will be reported with 95% confidence intervals

The percentage of participants with each identified type of pathogenic, or likely pathogenic, will be reported with 95% confidence intervals

The percentage of participants with identified variants of uncertain significance will be reported with 95% confidence intervals.

Participants who decline genetic testing but agree to participate in other study procedures will complete a Declination Survey which consists of one questions asking the reason for the decision to decline germline testing.

The rate of study completion defined as the percentage of participants who agree to testing, and complete all study procedures through return of results and meeting with genetic counselor (as appropriate) will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms	NCT05316480	Pancreatic Neur...	Nimotuzumab	18 Years - 80 Years	Fudan University
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms	NCT05746182	Pancreatic Neur...	Hereditary Canc...	18 Years -	University of California, San Francisco
Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms	NCT05316480	Pancreatic Neur...	Nimotuzumab	18 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for pancreatic neuroendocrine neoplasm